Phase 2
N=28
Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
Recurrent Uterine Corpus Sarcoma · Uterine Carcinosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00114218 ↗Enrolled (actual)
28
Serious AEs
45.8%
Results posted
Oct 2018
Primary outcome: Primary: Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0 — 8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine Hydrochloride (Drug); Docetaxel (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0 |
8 | — |
| PRIMARY Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 |
18 | — |
Summary
This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed uterine carcinosarcoma
- Malignant mixed Müllerian tumor, homologous or heterologous type
- Recurrent or persistent disease
- Progressive disease after prior local therapy
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- At least 1 target lesion
- Tumors within a previously irradiated field are not considered target lesions except documented progression or biopsy to confirm persistence at least 90 days after completion of radiation therapy
- Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma
- Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
- Performance status - GOG 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- No severe pulmonary disease requiring oxygen supplementation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No neuropathy (sensory or motor) > grade 1
- At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy
- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent or persistent disease
- Recovered from prior chemotherapy
- No more than 1 prior cytotoxic chemotherapy regimen, either as a single agent or combination therapy
- No prior docetaxel or gemcitabine
- At least 1 week since prior hormonal therapy for the malignancy
- Concurrent hormone replacement therapy allowed
- Recovered from prior radiotherapy
- Recovered from prior surgery
- At least 3 weeks since other prior therapy for the malignancy
- No prior cancer treatment that would preclude study therapy
Data sourced from ClinicalTrials.gov (NCT00114218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.